How to do a good job in the design of plastic flex

2022-07-25
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How to do a good job in the design of plastic flexible packaging large infusion project (Part 2)

non PVC multi-layer coextrusion film is composed of PP, PE and other raw materials in physical compatibility. In the late 1980s and early 1990s, it developed rapidly and formed the third generation of infusion. The world's famous large infusion manufacturers (such as Fresenius, Braun, Baxter, famasia, Otsuka, Takeda, etc.) have large infusion products in this form of packaging. The use of multi-layer coextrusion film for large infusion has become a development trend at the end of the 20th century. The packaging material is soft, transparent and the film thickness is small, so the flexible packaging can complete the human body input of the liquid medicine through its own shrinkage without introducing air, so that the liquid medicine can avoid the pollution of the external air, ensure the safe use of the infusion, and realize the closed infusion. As the third generation of large infusion, its main features are as follows:

1. bag making, printing, filling and sealing are completed on the same production line. The cylinder membrane is used without washing, so as to avoid pollution in the production process; It is a one-time packaging, which can not be repeatedly converted, changed or used innovatively, and there is no cross contamination; There is no environmental pollution in recycling

soft bag infusion meets the needs of manufacturers, businesses, medical staff and patients. It will replace the old glass bottles and other open infusion in the domestic market and become the main packaging form of large infusion in the future. Therefore, the market prospect is broad

large infusion is a commonly used first-aid drug, which is in great demand in clinic. According to statistics, the per capita consumption of large infusion in developed countries is 3 bottles/year. Based on this calculation, the potential large infusion Market in China is about 3.5 billion bottles/year. At present, the large infusion Market in rural China has not been developed. According to urban statistics, the per capita consumption of large infusion is only about 1 bottle/year, which shows that there is still a huge market space in China, and the timely development of large infusion industry has broad market prospects

the current situation of large-scale infusion production in China is also extremely unbalanced. The vast majority of manufacturers still produce large-scale infusion in traditional glass bottles, and the factory buildings are old and the equipment conditions are simple, which can not meet the GMP requirements. Now, the large-scale infusion in plastic bags, which integrates bag making, filling, sealing and other processes, has gradually replaced the traditional large-scale infusion in glass bottles with its advantages of light weight, simplified process, stable quality, strong safety and long term of validity, and has become a development trend

the infusion manufacturing process and equipment of non PVC composite film packaging are advanced, with high technical content and stable product quality. Compared with glass bottle packaging, it has changed the disadvantages of heavy and fragile packaging containers, difficult transportation and turnover, inconvenient use, high requirements for storage and transportation conditions, and the products are prone to quality problems during storage. It is suitable for safe infusion in outdoor and unclean environments. It is widely welcomed by medical personnel. It is the development direction of international infusion packaging containers today

IV. brief introduction to the design of infusion projects

Tianjin Pharmaceutical Design Institute has been engaged in pharmaceutical factory design for nearly 40 years (see Annex 1), and many projects designed in recent years have passed GMP certification (see Annex 2). Our institute has designed many large infusion plants (see Annex 3). We have a lot of experience in the design of large soft bag infusion. We have communicated with experts here. We have also found some noteworthy problems in the design. Here, I would like to talk about my views and discuss with experts

v. problems found in the design

some enterprises have not produced drugs, products, engineering and technical personnel, production experience and process of large infusion, and have not provided design conditions, so they require the design institute to make a general soft bag design. This is very difficult for design institutes that have not made soft bags, but for experienced design institutes, although they can make designs, they may cause losses to Party A due to their blindness and little pertinence

VI. put forward my views on the above problems

1 The design institute is not a research institute. It cannot develop products and formulate production process and operating procedures for Party A

the design institute shall, in accordance with the product dosage form, variety, annual production capacity, bag shape, specification, outer packaging method, production process and requirements, production and operation habits, annual working days, shift system, labor time and other design conditions proposed by Party A, and according to the site conditions provided by the production site, the terrain, shape and size, surrounding environment, traffic conditions, meteorological and natural conditions, hydrology The geology also has excellent high-temperature resistance and high-temperature corrosion resistance, specifications of water, electricity, steam, air, cooling and other power media in the plant, pipeline location, available quantity, quality, price and other site related conditions. The design, calculation, drawing, equipment selection, material balance and heat (energy) balance of equipment matching are carried out in accordance with the current applicable specifications. According to the process flow and equipment selection, carry out civil engineering and public engineering design, individual design and overall design of workshop, power room and supporting rooms, and carry out budget estimation and economic analysis. Only when Party A's design conditions and site conditions are implemented, can the design institute make scientific, correct, real, mature and economic design based on these conditions, and carry out design without determined production conditions and site power conditions, Like the blind riding a blind horse and facing the deep pool at midnight, the use of such design may make the project fall into the abyss

as non PVC soft bag large infusion is a new product developed from European and American countries in recent years, its production equipment is not qualified in China and needs to be introduced from abroad. It has become a central issue for many manufacturers of soft bag projects to introduce equipment of which country and brand. Through contact with agents, they go abroad to investigate production and use, understand equipment performance and maintenance services, and compare prices. Everyone is considering which equipment is the first to be imported, the product quality is the best, the production is the most stable, the most convenient to operate, and the most favorable conditions for maintenance and service. The price should be cheap and the brand is the most famous. For a while, managers "plomer", "PDC", "tianmuni", "finaqua" and "stimayan" shared their own views: "in the next five years, ness", "jieding"... Imported equipment brands have become the most talked about words, as if this is the technical core of soft bag infusion. But I think it is much more important to introduce the mature process of soft bag production, production technology operation specifications and production technology management system (which can be referred to as technical software above) than to introduce production equipment. Here, I will give you a few examples to explain:

the best equipment + no mature process and technical software = (1) unable to produce normally (2) unqualified products (3) high cost, Low economic benefit means no success

foreign mature processes and technology management should be introduced at a cost

the production of non PVC composite film soft bag large infusion began in Europe and the United States in recent 10 years. The content is new, the technology is complex, and there are many technical points to master. The main equipment used still needs to be imported from abroad. It is slow and costly to master the use and maintenance of these equipment by relying on domestic experience. It is suggested to seek foreign technical service providers to provide technical support, which will help to improve the soft bag infusion project in a multi, fast, good and economical way. It is not difficult to sum up this point from the successful experience and lessons of failure in China. We believe that the introduction of technical software is more important than the selection of foreign equipment

in addition, there must be a mature production process. Due to the difference between soft bags and glass bottles and hard plastic bottles, and between non PVC and PVC soft bags, due to the complexity and Avantgarde nature of non PVC multi-layer coextrusion films, hoses and mouth parts, and the progressiveness and complexity of equipment, a mature production process must be used. Without mature technology, no matter how good the equipment is, it can not produce qualified products. There are more than 10 main processes and many key process points in the production of soft bags. If any key point goes wrong, the product will be disqualified or discontinued. Because Chinese pharmaceutical enterprises (including the first-class large infusion manufacturers in China) are unfamiliar with the production process of non PVC coextrusion film soft bag infusion, any manufacturer preparing to successfully produce soft bag infusion should seek foreign production processes that have been skilled and qualified, and technical personnel who guide production and control quality, so as to lead the technical personnel of the factory in production

the conditions of the two projects are different, and the design cannot be the same. In order to turn the envisaged plant into reality, there must be a reliable design. The design should be carried out step by step. Several schemes should be made, and the technology and economy should be compared and selected. This is a feasible content. After the scheme is determined, the preliminary design should be made, the technology and budget estimates should be reviewed, and the construction drawing design should be carried out after adjustment, so as to ensure that the scheme is correct and each discipline is properly configured, The drawings are clear and accurate, which is conducive to construction

VII. Conclusion

to sum up, the following points should be paid attention to in order to improve the soft bag infusion project:

1. there should be certain products

2. determine the membrane nozzle fittings of the soft bag, and design the bag type

3. there should be mature and reliable production process, strict production operation procedures and equipment management procedures

4. we should pay attention to the introduction of technical software. China's plastic extruder industry is moving towards a healthy and sustainable development, and we should invest in the introduction of software

5. pay attention to the performance price ratio in equipment modeling, pay attention to being advanced, applicable, reliable and convenient, and do not blindly pursue famous brands and excessive configuration

6. on the premise of meeting production and use requirements and ensuring GMP certification, minimize project investment, minimize power consumption, reduce product costs, improve economic benefits and put economy first

7. have product strategy and price strategy suitable for market competition

8. provide the design institute with as detailed production, equipment conditions, site and power conditions as possible, give the design institute sufficient design time and sufficient design fee, advance step by step according to the capital construction procedure, let the design institute design an advanced, cost-effective and efficient scheme, and enable Party A to obtain the maximum comprehensive benefits

9. form a project leading group to do a good job in the management of all parts and disciplines of the project

the above opinions are not necessarily correct. They are for your reference during the implementation of the project. Please discuss and correct any improper points in this article

Tianjin Pharmaceutical Design Institute yuanmingli

source: Beijing Yalong

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